Application 206039
- Type
- ANDA
- Sponsor
- EXELA PHARMA SCS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MAGNESIUM SULFATE | MAGNESIUM SULFATE | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 5GM/10ML (500MG/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A206039-001 | MAGNESIUM SULFATE | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | 2014-12-18 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A206039-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | 2014-12-18 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A206039-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | 2014-12-18 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A206039-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | 2014-12-18 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206039-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | 2014-12-18 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206039-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | 2014-12-18 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206039-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | 2014-12-18 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206039-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | 2014-12-18 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206039-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | 2014-12-18 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206039-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | 2014-12-18 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206039-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | 2014-12-18 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206039-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | 2014-12-18 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A206039-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | 2014-12-18 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206039-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | 2014-12-18 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206039-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | 2014-12-18 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206039-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | 2014-12-18 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A206039-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | 2014-12-18 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A206039-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | 2014-12-18 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A206039-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | 2014-12-18 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A206039-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | 2014-12-18 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A206039-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | 2014-12-18 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A206039-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | 2014-12-18 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A206039-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | 2014-12-18 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206039-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | 2014-12-18 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A206039-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | 2014-12-18 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A206039-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | 2014-12-18 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A206039-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | 2014-12-18 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A206039-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | 2014-12-18 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A206039-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | 2014-12-18 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A206039-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | 2014-12-18 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A206039-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | 2014-12-18 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A206039-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | 2014-12-18 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A206039-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | 2014-12-18 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A206039-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | 2014-12-18 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A206039-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | 2014-12-18 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A206039-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | 2014-12-18 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A206039-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | 2014-12-18 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A206039-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | 2014-12-18 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A206039-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | 2014-12-18 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A206039-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | 2014-12-18 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A206039-001 | MAGNESIUM SULFATE | 5GM/10ML (500MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | AP | 2014-12-18 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206039-001 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206039-001 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206039-001 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A206039-001 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A206039-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A206039-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A206039-001 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A206039-001 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A206039-001 | AP | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A206039-001 | AP | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206039-001 | AP | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A206039-001 | AP | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A206039-001 | AP | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A206039-001 | AP | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A206039-001 | AP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A206039-001 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A206039-001 | AP | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A206039-001 | AP | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A206039-001 | AP | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A206039-001 | AP | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A206039-001 | AP | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A206039-001 | AP | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A206039-001 | AP | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A206039-001 | AP | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A206039-001 | AP | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A206039-001 | AP | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A206039-001 | AP | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A206039-001 | AP | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A206039-001 | AP | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A206039-001 | AP | 1 | cb3db0bc1861… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Epsom Salt | MAGNESIUM SULFATE | Target Corporation | 87f98e6c-a3a1-4ca5-bd56-977e38f48914 | 2026-09-04 | Warnings, Adverse reactions | MAGNESIUM SULFATE |
| Magnesium Sulfate | MAGNESIUM SULFATE HEPTAHYDRATE | Medical Purchasing Solutions, LLC | 5a0f9db9-b8be-c923-e063-6394a90a7dd7 | 2026-08-27 | Warnings, Adverse reactions | Magnesium Sulfate |
| Epsom Salt | MAGNESIUM SULFATE | Cardinal Health, 110 dba Leader | d27dc1cc-5e17-40d3-84fe-c1792552cfd5 | 2026-08-25 | Warnings, Adverse reactions | MAGNESIUM SULFATE |
| Magnesium Sulfate in Water | MAGNESIUM SULFATE | WG Critical Care, LLC | 752f55bb-c4ca-4545-94b3-3deea66888d4 | 2026-08-25 | Warnings, Adverse reactions | MAGNESIUM SULFATE |
| Magnesium Sulfate | MAGNESIUM SULFATE HEPTAHYDRATE | REMEDYREPACK INC. | 8c6b8b3d-9c04-4ed7-86b8-89065b6bf50d | 2026-08-24 | Warnings, Adverse reactions | Magnesium Sulfate |
| Epsom Salt | MAGNESIUM SULFATE | Safeway Inc | 0b757160-f9eb-4413-9b43-97544c49c72f | 2026-08-10 | Warnings, Adverse reactions | MAGNESIUM SULFATE |
| Epsom Salt | MAGNESIUM SULFATE | Vi-Jon, LLC | ba490c22-19f0-4887-9509-bd3d32e0f5b1 | 2026-06-24 | Warnings, Adverse reactions | MAGNESIUM SULFATE |
| Epsom Salt | MAGNESIUM SULFATE | CVS PHARMACY, INC | 1f9e72dc-a394-420d-8fe8-fc4d0f6906ed | 2026-05-27 | Warnings | MAGNESIUM SULFATE |
| Magnesium Sulfate | MAGNESIUM SULFATE | Hospira, Inc. | d4b5863a-efb9-4551-a9ad-2b06e8666d87 | 2026-04-23 | Warnings, Adverse reactions | Magnesium Sulfate MAGNESIUM SULFATE |
| Epsom Salt | MAGNESIUM SULFATE | Amazon.com Services LLC | 787ec4b0-c6c5-44ab-a53d-d6d25304f95e | 2026-03-03 | Warnings, Adverse reactions | MAGNESIUM SULFATE |
| Epsom Salt | MAGNESIUM SULFATE | Old East Main Co. | a8af6e2d-0052-4fc9-a51a-c9dbeb1ad3f5 | 2026-03-02 | Warnings, Adverse reactions | MAGNESIUM SULFATE |
| Epsom Salt | MAGNESIUM SULFATE | Chain Drug Marketing Association | 4ee26633-8eb1-4c68-a768-20460404533a | 2026-02-27 | Warnings, Adverse reactions | MAGNESIUM SULFATE |
| Epsom Salt | MAGNESIUM SULFATE | Meijer, Inc. | 3b8eae67-9e27-46bd-ab2b-02c719786bab | 2026-02-19 | Warnings, Adverse reactions | MAGNESIUM SULFATE |
| Epsom Salt | MAGNESIUM SULFATE | Meijer, Inc. | 2070a4a6-7968-49f2-84ec-53bd1cd82445 | 2026-02-19 | Warnings, Adverse reactions | MAGNESIUM SULFATE |
| Epsom Salt | MAGNESIUM SULFATE | United Natural Foods, Inc. dba UNFI | 5b4b4805-a8ff-4efe-94bc-411090ab5f9c | 2026-02-17 | Warnings, Adverse reactions | MAGNESIUM SULFATE |
| Epsom Salt | MAGNESIUM SULFATE | Valu Merchandisers Company | ff539c1c-9ed3-49be-9b30-1858f12e1e90 | 2026-02-16 | Warnings, Adverse reactions | MAGNESIUM SULFATE |
| Epsom Salt | MAGNESIUM SULFATE | Topco Associates LLC | b2ec06b3-647d-49ab-a392-6db63d96d1e3 | 2026-02-13 | Warnings, Adverse reactions | MAGNESIUM SULFATE |
| Epsom Salt | MAGNESIUM SULFATE | Topco Associates LLC | 72f69aa0-381a-4e5c-975d-3a73fdc1b377 | 2026-02-13 | Warnings, Adverse reactions | MAGNESIUM SULFATE |
| Magnesium Sulfate | MAGNESIUM SULFATE | Hospira, Inc. | e175d329-315f-4f3b-bb4c-06ad4e042967 | 2026-02-12 | Warnings, Adverse reactions | Magnesium Sulfate MAGNESIUM SULFATE |
| 365 Whole Foods Market Epsom Salt | MAGNESIUM SULFATE | Whole Foods Market, Inc. | 4147cdd0-57f6-3857-e063-6394a90afecb | 2026-02-12 | Warnings, Adverse reactions | MAGNESIUM SULFATE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 51754-1000 | Magnesium Sulfate | MAGNESIUM SULFATE HEPTAHYDRATE | Exela Pharma Sciences, LLC | ANDA | Current |
| 70518-1607 | Magnesium Sulfate | MAGNESIUM SULFATE HEPTAHYDRATE | REMEDYREPACK INC. | ANDA | Current |